多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.193323333181333123370533313333490.63
2 10.203337333354333640.05
单位质量响应值RSD%判断
3272.723270.980.04数据可信
供试品溶液-H147S批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114422-1442239.54837.994.3839.5537.994.38
213945-1394538.24038.24
314605-1460540.05040.05
413221-1322136.25536.25
513807-1380737.86237.86
613122-1312235.98335.98
10min122553-2255361.84561.122.0261.9161.182.02
222252-2225261.02061.08
322961-2296162.96463.03
421829-2182959.86059.92
522372-2237261.34961.41
621772-2177259.70359.76
15min126822-2682273.55273.221.1973.7273.391.19
226679-2667973.15973.32
327266-2726674.76974.94
426357-2635772.27672.44
526519-2651972.72172.89
626573-2657372.86973.03
20min129113-2911379.83480.151.2880.1380.441.27
229405-2940580.63580.92
329883-2988381.94582.24
428822-2882279.03679.32
529035-2903579.62079.91
629109-2910979.82380.10
30min131640-3164086.76487.001.1387.1987.421.13
231945-3194587.60088.02
332323-3232388.63689.07
431474-3147486.30886.72
531335-3133585.92786.35
631650-3165086.79187.20
45min133243-3324391.15991.281.3291.7391.841.32
233405-3340591.60492.17
334103-3410393.51894.10
433028-3302890.57091.13
533043-3304390.61191.17
632896-3289690.20890.77
60min133809-3380992.71193.011.0993.4393.731.09
233984-3398493.19193.91
334575-3457594.81295.55
433937-3393793.06293.77
533495-3349591.85092.56
633705-3370592.42693.14
90min134338-3433894.16294.201.1095.0495.071.10
234617-3461794.92795.80
334894-3489495.68796.58
434374-3437494.26195.12
533932-3393293.04993.92
633949-3394993.09593.96
120min134407-3440794.35194.811.2095.3895.841.20
234565-3456594.78595.82
335286-3528696.76297.82
434468-3446894.51995.54
534029-3402993.31594.34
634681-3468195.10396.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限135033-3503396.06896.050.9997.2697.240.99
235167-3516796.43597.63
335593-3559397.60498.82
434987-3498795.94297.12
534579-3457994.82396.00
634807-3480795.44896.62
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.193347933084331733349833605333680.68
2 10.203360633676336410.15
单位质量响应值RSD%判断
3274.583298.140.51数据可信
供试品溶液-H149S批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113080-1308035.71034.452.6335.7134.452.62
212551-1255134.26634.27
312086-1208632.99633.00
412784-1278434.90234.90
512707-1270734.69234.69
612508-1250834.14934.15
10min122189-2218960.57958.372.3160.6458.432.31
221283-2128358.10658.16
320688-2068856.48156.54
421460-2146058.58958.65
521508-2150858.72058.78
621158-2115857.76457.82
15min126264-2626471.70470.671.6071.8670.821.60
225878-2587870.65170.80
325728-2572870.24170.39
426328-2632871.87972.03
525914-2591470.74970.90
625189-2518968.76968.92
20min128907-2890778.92078.822.0079.2079.102.00
227983-2798376.39776.67
329447-2944780.39480.66
428970-2897079.09279.37
529468-2946880.45280.73
628454-2845477.68377.95
30min131222-3122285.24085.431.3985.6585.831.38
230486-3048683.23183.63
331462-3146285.89686.30
431709-3170986.57086.98
531572-3157286.19686.60
631287-3128785.41885.82
45min132619-3261989.05489.961.6689.6190.501.66
232319-3231988.23588.77
333580-3358091.67892.22
433241-3324190.75391.30
533473-3347391.38691.94
632469-3246988.64589.18
60min133461-3346191.35391.921.8692.0692.621.85
232636-3263689.10189.79
334101-3410193.10093.80
434379-3437993.85994.56
533980-3398092.77093.47
633451-3345191.32692.01
90min134034-3403492.91893.511.7793.7794.361.77
233171-3317190.56191.39
334318-3431893.69394.54
434929-3492995.36196.22
534582-3458294.41495.27
634475-3447594.12194.96
120min134226-3422693.44293.911.6394.4594.921.63
233386-3338691.14892.13
334848-3484895.14096.15
434828-3482895.08596.10
534747-3474794.86495.88
634355-3435593.79494.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134808-3480895.03194.841.2096.2096.001.20
234183-3418393.32494.46
335157-3515795.98397.15
435159-3515995.98997.17
534816-3481695.05296.23
634308-3430893.66694.82
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.193378733642340033388233641337910.47
2 10.203419934075341370.26
单位质量响应值RSD%判断
3316.093346.760.66数据可信
供试品溶液-H147S批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17068-706819.03617.0711.2719.0417.0711.26
27123-712319.18419.18
35700-570015.35115.35
45475-547514.74514.75
56684-668418.00218.00
65983-598316.11416.11
10min111507-1150730.99130.433.0731.0230.463.07
211693-1169331.49231.52
311082-1108229.84629.87
411074-1107429.82529.85
511604-1160431.25231.28
610840-1084029.19529.22
15min115199-1519940.93440.810.8541.0240.890.85
215342-1534241.31941.40
315183-1518340.89140.97
415141-1514140.77840.85
515113-1511340.70340.78
614950-1495040.26440.34
20min118186-1818648.97948.771.5249.1348.921.52
218554-1855449.97050.12
318007-1800748.49748.64
418231-1823149.10049.24
517867-1786748.12048.27
617808-1780847.96148.10
30min122154-2215459.66659.211.4059.9059.441.39
222299-2229960.05660.29
321857-2185758.86659.09
422020-2202059.30559.53
522144-2214459.63959.87
621440-2144057.74357.97
45min125754-2575469.36169.041.7169.6969.361.71
226273-2627370.75971.10
325599-2559968.94469.27
425864-2586469.65869.98
525246-2524667.99368.32
625062-2506267.49867.82
60min127856-2785675.02275.191.4375.4775.631.42
228251-2825176.08676.54
328082-2808275.63176.07
428324-2832476.28376.72
527752-2775274.74275.19
627244-2724473.37473.81
90min130807-3080782.97082.731.3283.5483.301.32
231161-3116183.92484.51
330876-3087683.15683.72
431021-3102183.54784.11
530258-3025881.49282.06
630181-3018181.28481.84
120min132218-3221886.77087.451.6887.4888.151.68
232727-3272788.14188.86
332668-3266887.98288.68
433120-3312089.20089.91
532554-3255487.67588.38
631528-3152884.91285.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132367-3236787.17288.401.3488.0389.261.34
233302-3330289.69090.56
332913-3291388.64289.49
433314-3331489.72290.58
532743-3274388.18489.03
632306-3230687.00787.84
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